US FDA Issues 69 New And Revised Draft Product-Specific Guidances

Maryland, 3 June 2020:

The US Food and Drug Administration (FDA) on Wednesday released 26 new and 43 revised draft product-specific guidances to support the development of generic drugs.

The guidances, when finalized, are intended to promote generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug. So far, FDA has issued a total of 1,903 product-specific guidances.

The latest batch follows the release of 43 new and revised product-specific guidances in March. (RELATED: FDA issues 43 product-specific guidances for generic drugs, Regulatory Focus 2 March 2020).

Among the newly added product-specific guidances are recommendations to support abbreviated new drug applications (ANDAs) for generic versions of Astellas Pharma’s acute myeloid leukemia drug Xospata (gilteritinib), Pfizer’s PARP inhibitor Talzenna (talazoparib), ViiV Healthcare’s HIV-1 treatment Dovato (dolutegravir/lamivudine), Fresenius Kabi’s Omegaven (fish oil triglycerides), subcutaneous buprenorphine and extended-release metformin.

FDA says the product specific guidance for subcutaneous buprenorphine is the first “for a poly(lactide-co-glycolide)- or PLGA-based product and it recommends a single dose parallel design comparative in vivo pharmacokinetic study to demonstrate bioequivalence.”

The newly revised product-specific guidances include altered recommendations for generic versions of AstraZeneca’s type 2 diabetes drugs Farxiga (dapagliflozin) and Qtern (dapagliflozin and saxagliptin), Keryx Biopharmaceuticals’ renal failure treatment Auryxia (ferric citrate) and transdermal buprenorphine.

FDA notes that 36 of the new and revised product specific guidances are for products with no approved generics and 34 of the guidances are for complex products.

FDA also updated its lists of product-specific guidances it plans to issue or revise in the coming year. Regulatory Focus